ANCA-Associated Vasculitis (AAV)Phase 1/2NCT07800871
FT839 in Autoimmune Diseases
A Phase 1/2 study testing FT839 in people with ANCA-Associated Vasculitis (AAV) and Idiopathic Inflammatory Myositis (IIM), run by Fate Therapeutics at 1 site in United States.
Trial summary
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA)
- What is being tested?
- FT839
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2040
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 to ≤70 years
- Must have active B-cell mediated autoimmune disease (AAV, IIM, RA, SLE, or SSc) confirmed by standard criteria
- Moderate to severe disease, requiring at least two prior treatments that were ineffective
- Adequate organ function to tolerate treatment
- Able to provide informed consent and comply with study procedures
Who cannot join
- Diagnosis of more than 1 disease under study (AAV, IIM, RA, SSc, or SLE) or overlap syndrome
- Women must not be pregnant or nursing
- Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
- Active or chronic infections
- Active or recent malignancies
- Prior CAR T-cell therapy or organ transplantation
Show all 10Show fewer
- Known allergies to study treatments
- Body weight <45 kg
- Active central nervous system (CNS) symptoms attributable to autoimmune disease or nonmalignant CNS disease within 12 months prior to trial intervention
- Receipt of any anti-CD19- or anti-CD20-directed therapy within 6 months prior to trial intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natalie Shiff, MD contact
United States1 site, 1 recruiting
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
About this study
Official title: An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.
Read the detailed description
This is a multicenter, Phase 1/2, open-label trial designed to evaluate the safety, pharmacokinetics (PK), anti-B-cell activity, and clinical activity of FT839 in participants with moderate-to-severe ANCA-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc).
Participants will receive FT839 as monotherapy or in combination with rituximab, with or without conditioning therapy and/or stable background therapy. Participants will be enrolled in 2 stages during the Phase 1 portion of the trial: a dose-escalation stage and a dose-expansion stage. In the dose-escalation stage, safety and tolerability will be assessed to define the MTD (or through the maximum assessed dose [MAD] in the absence of dose-limiting toxicities [DLTs] defining the MTD). The DLT evaluation period will extend from Day 1 through Day 29. Participants will be followed during the post-treatment follow-up period for up to 2 years after the first dose of FT839, followed by long-term-follow-up for safety and survival for up to 15 years after the first dose of FT839.
In the dose-expansion stage, participants will be enrolled into disease-specific cohorts to further evaluate the safety and activity of FT839.
Following completion of the Phase 1 portion, the Phase 2 portion of the trial will further evaluate the efficacy of FT839 within each disease cohort.
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
- Being tested
- FT839
- Keywords
- FT839, Fate Therapeutics, Allogenic CAR T, CD19 - targeted therapy, CD38 - targeted therapy, ANCA-associated vasculitis, Rheumatoid arthritis, Systemic sclerosis, Idiopathic inflammatory myositis, Dermatomyositis, Polymyositis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Dermatomyositis, Polymyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT839Biological
Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4
| Study group | Role | What they receive |
|---|---|---|
| FT839 + Rituximab (Regimen A) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| FT839 + Rituximab with stable background therapy (Regimen B) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| FT839 monotherapy (Regimen C) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| FT839 with stable background therapy (Regimen D) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| Conditioning + FT839 + Rituximab (Regimen E) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| Conditioning + FT839 + Rituximab with stable background therapy (Regimen F) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| Conditioning + FT839 (Regimen G) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
| Conditioning + FT839 with stable background therapy (Regimen H) | Experimental | FT839, allogeneic T cells targeting CD19 and CD38 Receives: Biological: FT839 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events
Incidence and severity of dose-limiting Toxicity (DLT)s, adverse event (AE)s, and serious adverse event (SAE)s
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Birmingham Vasculitis Activity Score
Birmingham Vasculitis Activity Score (BVAS) will be measured to evaluate the efficacy of FT839 in AAV. The BVAS score ranges from 0 to 63, with lower scores indicating better outcomes.
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Manual muscle testing-8
Manual muscle testing-8 (MMT-8) will be measured to evaluate the efficacy of FT839 in IIM. The MMT-8 score ranges from 0 to 150, with higher scores indicating better outcomes.
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Disease Activity Score using 28 joint counts and C-reactive protein (a composite measure)
Disease Activity Score using 28 joint counts and C-reactive protein (DAS28-CRP) will be measured to evaluate the efficacy of FT839 in RA. The validated composite measure DAS28-CRP score ranges from 0.0 to 9.4, with lower scores indicating better outcomes.
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in SLE Disease Activity Index 2000
SLE Disease Activity Index 2000 (SLEDAI-2K) score will be measured to evaluate the efficacy of FT839 in SLE. The SLEDAI-2K score ranges from 0 to 105, with lower scores indicating better outcomes.
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Change from baseline in Modified Rodnan skin score
Modified Rodnan skin (mRSS) score will be measured to evaluate the efficacy of FT839 in SSc. The mRSS score ranges from 0 to 51, with lower scores indicating better outcomes.
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Secondary outcomes (4)
Phase 1: Maximum concentration and area under the curve of FT839 in peripheral blood
Pharmacokinetics (PK) of FT839 in peripheral blood including but not limited to maximum concentration (Cmax) and area under the curve (AUC) will be estimated based on observed plasma concentration-time data.
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Incidence of AEs and SAEs
Incidence and severity of AEs and SAEs
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Cmax of FT839 in peripheral blood
PK of FT839 in peripheral blood including but not limited to Cmax will be estimated based on observed plasma concentration-time data
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: AUC of FT839 in peripheral blood
PK of FT839 in peripheral blood including AUC will be estimated based on observed plasma concentration-time data
Measured: From enrollment to the end of the post-treatment follow-up at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-Associated Vasculitis (AAV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800871
- Sponsor's protocol ID
- FT839-101
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07800871
- Acronym / sponsor ID
- FT839-101
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
- Keywords
- FT839, Fate Therapeutics, Allogenic CAR T, CD19 - targeted therapy, CD38 - targeted therapy, ANCA-associated vasculitis, Rheumatoid arthritis, Systemic sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2040 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.
Detailed description
This is a multicenter, Phase 1/2, open-label trial designed to evaluate the safety, pharmacokinetics (PK), anti-B-cell activity, and clinical activity of FT839 in participants with moderate-to-severe ANCA-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc).
Participants will receive FT839 as monotherapy or in combination with rituximab, with or without conditioning therapy and/or stable background therapy. Participants will be enrolled in 2 stages during the Phase 1 portion of the trial: a dose-escalation stage and a dose-expansion stage. In the dose-escalation stage, safety and tolerability will be assessed to define the MTD (or through the maximum assessed dose [MAD] in the absence of dose-limiting toxicities [DLTs] defining the MTD). The DLT evaluation period will extend from Day 1 through Day 29. Participants will be followed during the post-treatment follow-up period for up to 2 years after the first dose of FT839, followed by long-term-follow-up for safety and survival for up to 15 years after the first dose of FT839.
In the dose-expansion stage, participants will be enrolled into disease-specific cohorts to further evaluate the safety and activity of FT839.
Following completion of the Phase 1 portion, the Phase 2 portion of the trial will further evaluate the efficacy of FT839 within each disease cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| FT839 + Rituximab (Regimen A) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| FT839 + Rituximab with stable background therapy (Regimen B) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| FT839 monotherapy (Regimen C) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| FT839 with stable background therapy (Regimen D) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| Conditioning + FT839 + Rituximab (Regimen E) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| Conditioning + FT839 + Rituximab with stable background therapy (Regimen F) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| Conditioning + FT839 (Regimen G) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
| Conditioning + FT839 with stable background therapy (Regimen H) | Experimental | Biological: FT839FT839, allogeneic T cells targeting CD19 and CD38 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 to ≤70 years
- Must have active B-cell mediated autoimmune disease (AAV, IIM, RA, SLE, or SSc) confirmed by standard criteria
- Moderate to severe disease, requiring at least two prior treatments that were ineffective
- Adequate organ function to tolerate treatment
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (10 listed)
- Diagnosis of more than 1 disease under study (AAV, IIM, RA, SSc, or SLE) or overlap syndrome
- Women must not be pregnant or nursing
- Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
- Active or chronic infections
- Active or recent malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT839Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4 | Biological | Conditioning + FT839 (Regimen G), Conditioning + FT839 + Rituximab (Regimen E), Conditioning + FT839 + Rituximab with stable background therapy (Regimen F), Conditioning + FT839 with stable background therapy (Regimen H), FT839 + Rituximab (Regimen A), FT839 + Rituximab with stable background therapy (Regimen B), FT839 monotherapy (Regimen C), FT839 with stable background therapy (Regimen D) |
Primary outcome
Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Incidence and severity of dose-limiting Toxicity (DLT)s, adverse event (AE)s, and serious adverse event (SAE)s
Phase 2: Change from baseline in Birmingham Vasculitis Activity Score
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Birmingham Vasculitis Activity Score (BVAS) will be measured to evaluate the efficacy of FT839 in AAV. The BVAS score ranges from 0 to 63, with lower scores indicating better outcomes.
Phase 2: Change from baseline in Manual muscle testing-8
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Manual muscle testing-8 (MMT-8) will be measured to evaluate the efficacy of FT839 in IIM. The MMT-8 score ranges from 0 to 150, with higher scores indicating better outcomes.
Phase 2: Change from baseline in Disease Activity Score using 28 joint counts and C-reactive protein (a composite measure)
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Disease Activity Score using 28 joint counts and C-reactive protein (DAS28-CRP) will be measured to evaluate the efficacy of FT839 in RA. The validated composite measure DAS28-CRP score ranges from 0.0 to 9.4, with lower scores indicating better outcomes.
Phase 2: Change from baseline in SLE Disease Activity Index 2000
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
SLE Disease Activity Index 2000 (SLEDAI-2K) score will be measured to evaluate the efficacy of FT839 in SLE. The SLEDAI-2K score ranges from 0 to 105, with lower scores indicating better outcomes.
Phase 2: Change from baseline in Modified Rodnan skin score
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Modified Rodnan skin (mRSS) score will be measured to evaluate the efficacy of FT839 in SSc. The mRSS score ranges from 0 to 51, with lower scores indicating better outcomes.
4 secondary outcomes
Phase 1: Maximum concentration and area under the curve of FT839 in peripheral blood
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Incidence of AEs and SAEs
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: Cmax of FT839 in peripheral blood
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Phase 2: AUC of FT839 in peripheral blood
Time frame: From enrollment to the end of the post-treatment follow-up at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for ANCA-Associated Vasculitis (AAV)
Not yet recruitingObservational study
Qualitative Study With Focus Groups of People Living With ANCA-associated Vasculitis (AAV) and Clinicians, to Explore Different Perspectives on Shared Decision-making in AAV.
ANCA Associated Vasculitis (AAV)
Not yet recruitingPhase 1/2
Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined With Immunosuppressants in the Treatment of Refractory Autoimmune Diseases
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
RecruitingPhase 1/2
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
RecruitingPhase 2
Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV)
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
IgA Nephropathy (IgAN), Membranous Nephropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Shiff, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FT839 in people with ANCA-Associated Vasculitis (AAV) and Idiopathic Inflammatory Myositis (IIM), run by Fate Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fate Clinical Trials (858-875-1800, clinicaltrials@fatetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events (time frame: From enrollment to the end of the post-treatment follow-up at 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.